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This session will follow the life of a biomarker from the nonclinical arena to its use in clinical trials. The characteristics of a useful biomarker will be discussed. Examples of protocol designs and statistical analysis approaches that use mechanism of action at the molecular level to inform go/no-go decisions will be discussed.

Learning Objectives

Describe the characteristics of a useful biomarker; Illustrate examples of protocol designs and statistical analysis approaches at the molecular level.

PhD in Statistics from Temple University 14 years of industry experience covering different phases of drug development from pre-clinical to phase III in multiple therapeutic areas Currently Director, statistics leader for Rare Diseases Unit at GSK

Bio Adam Cohen (b.1952) graduated in Pharmacy and Medicine from Leiden University. He subsequently joined the department of Clinical Pharmacology of the Wellcome Research Laboratories He obtained a PhD degree from Leiden University (1986). Since 1987 he is director of the Centre... Read More →